Develop and register a new fixed-dose combination of artesunate (AS) and mefloquine (MQ) in response to patient need
current phase of drug development
updated 31 May 2019
Short-course fixed-dose combination with long shelf-life decreases risk of resistance emerging
Easy-to-use malaria treatment with high cure rates
With older antimalarial medicines becoming less effective due to growing drug resistance, in 2001 WHO recommended the use of artemisinin-based combination therapies as the primary type of malaria treatment.
However, there were no combinations of the recommended drugs. People had to take each drug separately, which is more complicated and increases the chances of drug resistance developing due to people not taking the full and correct dose of both medicines.
DNDi and Farmanguinhos/Fiocruz partnered to combine two malaria drugs that had been widely used in Asia and Latin America for the last 20 years: artesunate and mefloquine. The partnership developed ASMQ – a tablet that is a fixed-dose combination of these two drugs. DNDi and its partners conducted several clinical trials to test its safety and effectiveness.
ASMQ is suitable for adults, children, and infants from 6 months of age, which is vital since children under five are most at risk of dying from malaria. ASMQ is easy-to-use because patients need to take just one dose per day for three days. Giving the medicine to infants and young children is easier because the tablets can be disintegrated in water. ASMQ has a three-year shelf-life in tropical conditions.
ASMQ offers a long period of protection after treatment and has a key role in the Greater Mekong Subregion, where there is increasing drug resistance. ASMQ was released at cost price to make it affordable and reach patients.
- Indication: Malaria
- Dosage: Single daily fixed-dose combination of artesunate & mefloquine for 3 days
- Registered in 11 countries and territories in Asia, Latin America, and Africa
- More than 1.2 million treatments distributed since 2008
- Recommended first or second-line treatment in five countries in Latin America and four countries in South-East Asia
- No patent: developed as a public good, so any generic company meeting quality standards can produce it
- Included in the Essential Medicines List (EML) and Essential Medicines List for children (EMLc) in 2013
- Technology transfer from Brazilian public sector laboratory Farmanguinhos/Fiocruz to Indian generic company Cipla in 2010
- Cipla’s product was prequalified by WHO in 2012
History – the FACT project
In response to WHO’s recommendation of artesunate combination therapies to treat malaria, Médecins Sans Frontières, the WHO Special Programme for Research and Training in Tropical Diseases, and other partners established the Fixed-Dose-Artesunate Combination Therapy (FACT) project in 2002. When DNDi was created in 2003, it took over management of the FACT project.
FACT’s objective was to develop two fixed-dose combination therapies containing artemisinin for the treatment of malaria. The urgency of these goals was confirmed by WHO’s 2006 malaria treatment guidelines calling for an immediate halt to artemisinin monotherapy, to prevent the creation of drug resistance. ASMQ was first released in 2008.
‘At night his body was very hot – he was sweating and vomiting. He looked very sick, so I decided to bring him at the hospital. The doctors found he had malaria. There is a lot of malaria in my community because of the rain. I am very happy now because he was treated.’
Mother of three-year old Michele who was treated with ASMQ, Ahero district, Kisumu, Kenya
News & resources
- 8 August 2016 - Comparison of artesunate–mefloquine and artemether–lumefantrine fixed-dose combinations for treatment of uncomplicated P. falciparum malaria in children under 5 years in sub-Saharan Africa: a randomised, multicentre, phase 4 trial, The Lancet Infectious Diseases
- 9 June 2015 - After more than a decade of effort and achievements, DNDi hands over malaria programme to MMV
- 19 March 2015 - A randomized trial to compare the safety, tolerability and effectiveness of three antimalarial regimens for the prevention of malaria in Nigerian patients with sickle-cell disease, The Journal of Infectious Diseases
- 6 November 2014 - DNDi Latin America Receives FINEP Innovation Award in Social Technology
- 4 November 2014 - Artesunate-Mefloquine Fixed-Dose Combination (ASMQ FDC) Proves Safe and Efficacious to Treat Children in Africa with Malaria
- 23 May 2014 - Population pharmacokinetics of mefloquine, administered as a fixed-dose combination of artesunate-mefloquine in Indian patients for the treatment of acute uncomplicated Plasmodium falciparum malaria, Malaria Journal
- 10 December 2013 - Safety, efficacy and population pharmacokinetics of fixed-dose combination of artesunate-mefloquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in India, J Vector Borne Dis
- 11 July 2013 - Three Neglected-Disease Treatments Newly Added to WHO Essential Medicines List for Paediatric Use
- 25 February 2013 - The story of artesunate-mefloquine (ASMQ), innovative partnerships in drug development: case study, Malaria Journal
- 3 October 2012 - Cipla-DNDi Press Release: WHO Prequalifies A New Artemisinin-Based Combination Treatment (ACT) for Malaria. Artesunate-Mefloquine Fixed-Dose Combination (ASMQ FDC) to be rolled out throughout Asia
- 24 April 2012 - Cipla and DNDi announce the forthcoming launch of Artesunate + Mefloquine fixed-dose combination for P. falciparum malaria
- 10 January 2011 - Effect of artesunate and mefloquine in combination on the Fridericia corrected QT intervals in Plasmodium falciparum infected adults from Thailand, Tropical Medicine and International Health
- 17 April 2008 - A Worldwide Public Partnership Makes Available a New, Once-a-Day Fixed-Dose Combination against Malaria
- 10 November 2006 - An open label randomized comparison of mefloquine–artesunate as separate tablets vs. a new co-formulated combination for the treatment of uncomplicated multidrug-resistant falciparum malaria in Thailand, Trop Med Int Health
Key scientific article:
Pharmacokinetics of co-formulated mefloquine and artesunate in pregnant and non-pregnant women with uncomplicated Plasmodium falciparum infection in Burkina Faso. Journal of Antimicrobial Chemotherapy, June 2014
by Valea I, Tinto H, Traore/Coulibaly M, Toe Niklas Lindegardh LC, Tarning J, Van Geertruyden JP, D’Alessandro U, Davies GR, Ward SA.
More about ASMQ:
*Project cost includes direct and indirect costs, but it does not include in-kind contributions.
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